Spectrum of National Institutes of Health-Funded Research in Cardio-Oncology: A Basic, Clinical, and Observational Science Perspective.
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ABSTRACT:
SUBMITTER: Adhikari BB
PROVIDER: S-EPMC9328446 | biostudies-literature | 2022 Jul
REPOSITORIES: biostudies-literature
Publications
Spectrum of National Institutes of Health-Funded Research in Cardio-Oncology: A Basic, Clinical, and Observational Science Perspective.
Adhikari Bishow B BB Shi Scarlet S Dimond Eileen P EP Shelburne Nonniekaye N Desvigne-Nickens Patrice P Minasian Lori M LM
Heart failure clinics 20220701 3
Advances in cancer treatments have led to nearly 17 million survivors in the US today. Cardiovascular complications attributed to cancer treatments are the leading cause of morbidity and mortality in cancer survivors. In response, NCI and NHLBI held 2 workshops and issued funding opportunities to strengthen research on cardiotoxicity. A representative portfolio of NIH grants categorizing basic, interventional, and observational projects is presented. Compared with anthracyclines, research on rad ...[more]
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Project description:The translation of biomedical research from basic knowledge to application has been a priority at the National Institute of Health (NIH) for many years. Tracking the progress of scientific research and knowledge through the translational process is difficult due to variation in the definition of translational research as well as the identification of benchmarks for the spread and application of biomedical research; quantitatively tracking this process is even more difficult. Using a simple and reproducible method to assess whether publications are translational, we examined NIH R01 behavioral and social science research (BSSR) awards funded between 2008 and 2014 to determine whether there are differences in the percent of translational research publications produced by basic and applied research awards. We also assessed the percent of translational research publications produced by the Clinical and Translational Science Awards (CTSA) program to evaluate whether targeted translational research awards result in increased translational research. We found that 3.9% of publications produced by basic research awards were translational; that the percent of translational research publications produced by applied research awards is approximately double that of basic research awards (7.4%); and that targeted translational research awards from the CTSA program produced the highest percentage of translational research publications (13.4%). In addition, we assessed differences in time to first publication, time to first citation, and publication quality by award type (basic vs. applied), and whether an award (or publication) is translational.
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Project description:Overlapping commonalities between coronavirus disease of 2019 (COVID-19) and cardio-oncology regarding cardiovascular toxicities (CVT), pathophysiology, and pharmacology are special topics emerging during the pandemic. In this perspective, we consider an array of CVT common to both COVID-19 and cardio-oncology, including cardiomyopathy, ischemia, conduction abnormalities, myopericarditis, and right ventricular (RV) failure. We also emphasize the higher risk of severe COVID-19 illness in patients with cardiovascular disease (CVD) or its risk factors or cancer. We explore commonalities in the underlying pathophysiology observed in COVID-19 and cardio-oncology, including inflammation, cytokine release, the renin-angiotensin-aldosterone-system, coagulopathy, microthrombosis, and endothelial dysfunction. In addition, we examine common pharmacologic management strategies that have been elucidated for CVT from COVID-19 and various cancer therapies. The use of corticosteroids, as well as antibodies and inhibitors of various molecules mediating inflammation and cytokine release syndrome, are discussed. The impact of angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) is also addressed, since these drugs are used in cardio-oncology and have received considerable attention during the COVID-19 pandemic, since the culprit virus enters human cells via the angiotensin converting enzyme 2 (ACE2) receptor. There are therefore several areas of overlap, similarity, and interaction in the toxicity, pathophysiology, and pharmacology profiles in COVID-19 and cardio-oncology syndromes. Learning more about either will likely provide some level of insight into both. We discuss each of these topics in this viewpoint, as well as what we foresee as evolving future directions to consider in cardio-oncology during the pandemic and beyond. Finally, we highlight commonalities in health disparities in COVID-19 and cardio-oncology and encourage continued development and implementation of innovative solutions to improve equity in health and healing.
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Project description:The clinical trials community has a never-ending search for dependable and reliable ways to improve clinical research. This exploration has led to considerable interest in adaptive clinical trial designs, which provide the flexibility to adjust trial characteristics on the basis of data reviewed at interim stages. Statisticians and clinical investigators have proposed or implemented a wide variety of adaptations in clinical trials, but specific approaches have met with differing levels of support. Within industry, investigators are actively exploring the benefits and pitfalls associated with adaptive designs (ADs). For example, a Drug Information Association (DIA) working group on ADs has engaged regulatory agencies in discussions. Many researchers working on publicly funded clinical trials, however, are not yet fully engaged in this discussion. We organized the Scientific Advances in Adaptive Clinical Trial Designs Workshop to begin a conversation about using ADs in publicly funded research. Held in November of 2009, the 1½-day workshop brought together representatives from the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the European Medicines Agency (EMA), the pharmaceutical industry, nonprofit foundations, the patient advocacy community, and academia. The workshop offered a forum for participants to address issues of ADs that arise at the planning, designing, and execution stages of clinical trials, and to hear the perspectives of influential members of the clinical trials community. The participants also set forth recommendations for guiding action to promote the appropriate use of ADs. These recommendations have since been presented, discussed, and vetted in a number of venues including the University of Pennsylvania Conference on Statistical Issues in Clinical Trials and the Society for Clinical Trials annual meeting.To provide a brief overview of ADs, describe the rationale behind conducting the workshop, and summarize the main recommendations that were produced as a result of this workshop.There is a growing interest in the use of adaptive clinical trial designs. However, a number of logistical barriers need to be addressed in order to obtain the potential advantages of an AD. Currently, the pharmaceutical industry is well ahead of academic trialists with respect to addressing these barriers. Academic trialists will need to address important issues such as education, infrastructure, modifications to existing funding models, and the impact on Data and Safety Monitoring Boards (DSMB) in order to achieve the possible benefits of adaptive clinical trial designs.
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Project description:ImportanceInvestigators applying for National Institutes of Health (NIH) funding increasingly use promotional language (or hype) that has the potential to undermine objective evaluation. Whether or not the same investigators use hype in subsequent research reports has yet to be investigated.ObjectiveTo assess changes in the use of hype in journal abstracts reporting research funded by the NIH and to compare those trends with previously reported trends in the associated NIH funding applications.Design, setting, and participantsThis cross-sectional study assessed trends (from 1985 to 2020) in the use of promotional adjectives in abstracts of journal articles reporting NIH-funded research, and then compared those trends with previously reported trends for the associated NIH funding applications. Articles included in analyses had abstracts available in PubMed.Main outcomes and measuresAbsolute change for the 139 adjective forms that have previously been identified as representing hype in NIH funding applications was measured as the difference in frequency between 1985 and 2020. Relative change was measured as the percentage change in frequency in 2020 relative to 1985, or the first year of occurrence. Consistency of change was measured by the rank order correlation (Kendall τ). Concordance between longitudinal trends in the journal abstracts and NIH funding applications was measured by the rank-order cross-correlation.ResultsIn a total of 2 394 480 journal abstracts, all 139 adjective forms were identified in 2 793 592 total occurrences. Among these adjectives, 133 increased in absolute frequency by 5335 words per million (wpm), with a mean (SD) relative increase of 1404% (2371%). The largest absolute increases were for novel (524 wpm), important (414 wpm), and key (378 wpm). The largest relative increases were for scalable (22 wpm [19 964%]), unmet (23 wpm [12 126%]), and tailored (40 wpm [8169%]). The mean (SD) correlation for all adjectives was 0.70 (0.30) with 95 adjectives showing a strong positive correlation (τ > 0.7; P < .001), 24 a moderate positive correlation (0.5 < τ < 0.7; P < .001), and 3 a moderate negative correlation (-0.5 < τ < -0.7; P < .001). The mean (SD) cross-correlation was 0.64 (0.19) with 61 of the 139 adjectives showing a strong positive cross-correlations (τ > 0.7; P < .001), 53 a moderate positive cross-correlations (0.5 < τ < 0.7; P < .001), and 3 a moderate negative cross-correlation (-0.7 < τ < -0.5; P < .001).Conclusions and relevanceIn this analysis of journal abstracts reporting NIH-funded research from 1985 to 2020, levels of promotional language were found to be increasing and trends were closely associated with previously reported trends in the related NIH funding applications. This suggests that increasing levels of salesmanship may in part be a downstream effect of salesmanship infused during earlier stages of the research cascade.
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